ELECTRO SURGERY SYSTEM— 510(k) K841165
Substantially EquivalentMicro-Aire Surgical Instruments, Inc.
FDA 510(k) clearance K841165 for ELECTRO SURGERY SYSTEM, Substantially Equivalent on 1984-06-05. Applicant: Micro-Aire Surgical Instruments, Inc..
Clearance details
- Applicant
- Micro-Aire Surgical Instruments, Inc.
- Product code
- Code GEY
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Adverse events under product code GEY
product code GEY- Malfunction
- 7,488
- Total
- 7,488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.